A randomized controlled study of Sofwave’s FDA-cleared Pure Impact VIP platform found functional gains, with most improvements sustained four weeks after treatment.
Sofwave Medical announced the publication of clinical study results in Aesthetic Surgery Journal, evaluating the functional performance and safety of its US Food and Drug Administration-cleared Pure Impact VIP platform utilizing PlyoPulse electrical muscle stimulation (EMS) technology.
The prospective, open-label, blank-controlled trial enrolled 38 healthy adults who were randomized equally into an active treatment group and an untreated control group. Participants in the treatment group underwent six weekly sessions targeting the abdomen, quadriceps, hamstrings, and glutes. Blinded evaluators assessed functional performance through standardized tests at baseline, week 5, and week 9, which took place four weeks after the final treatment. Evaluated movements included prone hip extensions, paced curl-ups, seated quadriceps extensions, and side plank endurance.
Objective Functional Gains
According to the study findings, the treatment group showed statistically significant improvements over baseline across all four functional tests by week 5. Prone hip extension repetitions increased by 68% (P<0.001), paced curl-up performance rose by 42% (P=0.0025), seated quadriceps extensions increased by 53% (P<0.001), and side plank endurance increased by 73% (P=0.0018).
All four functional measures demonstrated statistically significant differences favoring the treatment group compared with the control group at week 5, the company stated. Most of these gains persisted through the week 9 evaluation, where three of the four functional measures maintained statistically significant differences over the untreated control group, which showed minimal to no change.
“This publication adds an important layer of clinical evidence to our Pure Impact VIP platform by demonstrating that PlyoPulse’s synchronized, multi-muscle activation can produce measurable gains in objective functional performance, sustained through the four-week follow-up, not just aesthetic improvement,” says Louis Scafuri, CEO of Sofwave Medical, in a release. “As more patients look for non-invasive ways to support functional performance, particularly those concerned about muscle loss, data like these reinforce why physicians around the world are turning to Sofwave’s highly innovative and effective technology platforms.”
Subject Satisfaction and Tolerability
Patient-reported outcomes measured through the Body-Q questionnaire showed significant improvements in body image as well as satisfaction with the abdomen, buttocks, and inner thighs, according to the release. Additionally, 68% of treated participants reported feeling that their muscles were stronger and firmer.
The company reported that the procedure was well tolerated, with an average discomfort score of 1.2 on a 10-point scale, 82% of sessions rated as causing none-to-minimal discomfort, and no adverse events recorded during the trial.
According to the manufacturer, conventional devices typically stimulate an isolated muscle group in a single direction, whereas the PlyoPulse design uses rotating polarity and timed cycles to coordinate contractions across linked muscle groups to emulate movements such as squats and lunges.
“Most EMS research to date has focused on morphological change, such as muscle thickness, firmness and contour. This trial specifically measured objective functional performance using standardized repetition- and endurance-based testing,” says Kiya Movassaghi, MD, DMD, FACS, clinical assistant professor of plastic surgery at Oregon Health & Science University School of Medicine and lead author of the manuscript, in a release. “Subjects improved across all four functional tests at week 5, and most of those gains were sustained at week 9, four weeks after the final treatment. The improvements in functional performance combined with high tolerability suggest that a multidirectional electro muscular stimulation technology incorporating synchronized muscle recruitment and programmable contraction timing may promote neuromuscular adaptations.”
ID 100789046 © Pixs4u | Dreamstime.com
